Effects of Treatment of Sleep Apnea on Metabolic Syndrome

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-01-31

Study Completion Date

2008-09-30

Brief Summary

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The investigators performed a randomized, cross-over controlled clinical trial comparing 8 weeks of Continuous Positive Airway Pressure (CPAP) to 8 weeks of sham-CPAP in patients with moderate to severe Sleep Disordered Breathing (SDB) and impaired glucose tolerance. A rigorous assessment of metabolic responses to SDB treatment in this group is of great clinical significance because this sample is at high risk for developing diabetes. The paradigm shift of CPAP as a mode of prevention can affect clinical practice in the fields of both primary care and sleep medicine.

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Detailed Description

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There are few controlled studies that address whether treatment of sleep apnea improves glucose tolerance. This is a randomized, double-blind cross-over study of subjects with sleep apnea (apnea hypopnea index \> 15) and impaired glucose tolerance. Subjects will be randomized to 8 weeks of Continuous Positive Airway Pressure (CPAP) or sham-CPAP, followed by the alternate therapy after a one month wash-out. After each treatment, subjects will undergo 2-hour oral glucose tolerance testing, polysomnography, actigraphy, and measurements of indices of glucose control. The investigators intend to analyze the changes in glucose metabolism and insulin sensitivity in patients with sleep apnea with CPAP intervention.

Conditions

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Impaired Glucose Tolerance Obstructive Sleep Apnea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Continuous Positive Airway Pressure (CPAP)

Group Type ACTIVE_COMPARATOR

Continuous Positive Airway Pressure (CPAP) (Philips-Respironics RemStar Pro® CPAP)

Intervention Type DEVICE

Subjects will be randomized to 8 weeks of CPAP or sham-CPAP, followed by the alternate therapy after a one month wash-out.

Sham-Continuous Positive Airway Pressure (CPAP)

Group Type SHAM_COMPARATOR

Sham-Continuous Positive Airway Pressure (CPAP) (Philips-Respironics)

Intervention Type DEVICE

Subjects will be randomized to 8 weeks of CPAP or sham-CPAP, followed by the alternate therapy after a one month wash-out.

Interventions

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Continuous Positive Airway Pressure (CPAP) (Philips-Respironics RemStar Pro® CPAP)

Subjects will be randomized to 8 weeks of CPAP or sham-CPAP, followed by the alternate therapy after a one month wash-out.

Intervention Type DEVICE

Sham-Continuous Positive Airway Pressure (CPAP) (Philips-Respironics)

Subjects will be randomized to 8 weeks of CPAP or sham-CPAP, followed by the alternate therapy after a one month wash-out.

Intervention Type DEVICE

Other Intervention Names

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Philips-Respironics RemStar Pro® CPAP Philips-Respironics Sham CPAP

Eligibility Criteria

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Inclusion Criteria

* moderate to severe Sleep Disordered Breathing (SDB) defined by an Apnea Hypopnea Index (AHI) \> 15
* had evidence of Impaired Glucose Tolerance (IGT) defined by the mean 2-hour Oral Glucose Tolerance Test (OGTT) glucose of \> 140 mg/dl calculated from the two 2-hour OGTTs performed within 3 days of each other

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No